MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization in examination of the device and consecutive remedies.Upon contacting the hospital to obtain additional information it was further reported that the device was inspected by an engineer from the biomedical department and that the issue could be traced back to an occluded inlet filter of the vacuum pump.The device is reportedly back in use after replacement of the filter.Dräger concludes the following: the auxiliary vacuum pressure is needed to operate the valves which control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.The system effect of an occluded inlet filter for the vacuum pump is that the pump cannot build-up the necessary pressure upon which the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.It is recommended by dräger to check the workstation in regular intervals; inspection of the inlet filter and replacement based upon visual appearance are part of the service and maintenance procedure.It is seen likely that this was not consequently done in the particular case.

Event Description

It was reported that the device suddenly alarmed during use and stopped automatic ventilation; the issue did not lead to patient consequences.

Event Description

It was reported that the device suddenly alarmed during use and stopped automatic ventilation.The issue did not lead to patient consequences.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12175644
• MDR Text Key: 264087437
• Report Number: 9611500-2021-00308
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.; NA.